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Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Mcgaw Laboratories — Predicate Candidate Screening

3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K781230GAVAGE ADMIN. SETMcgaw Laboratories1978-09-07510
K760520CALIPERS, MCGAW SKINFOLDMcgaw Laboratories1976-11-12780
K760521TAPE MEASUREMcgaw Laboratories1976-11-12780

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda